COLLABORATION AGREEMENTS | 4. COLLABORATION AGREEMENTS The following table summarizes our total condensed Three Months Ended March 31, Description 2019 2018 Sanofi Genzyme $ 4,117 $ 18,853 The Medicines Company 1,745 1,295 Vir Biotechnology 928 1,242 Other 213 509 Total net revenues from collaborators $ 7,003 $ 21,899 The following table presents the balance of our receivables and contract liabilities related to our collaboration agreements at March 31, 2019 and December 31, 2018, in thousands: At March 31, 2019 At December 31, 2018 Receivables included in “Accounts receivable, net” $ 11,723 $ 5,625 Contract liabilities included in “Deferred revenue” 3,026 3,954 During the three months ended March 31, 2019, we recognized the following revenue as a result of the change in the contract liability balances related to our collaboration agreements, in thousands: Revenue recognized in the period from: Three Months Ended March 31, 2019 Amounts included in contract liability at the beginning of the period $ 928 In order to determine revenue recognized in the period from contract liabilities, we first allocate revenue to the individual contract liability balance outstanding at the beginning of the period until the revenue exceeds that balance. If additional consideration is received on those contracts in subsequent periods, we assume all revenue recognized in the reporting period first applies to the beginning contract liability as opposed to a portion applying to the new consideration for the period. The following table provides the research and development expenses incurred by type that are directly attributable to our collaboration agreements by our collaboration partners for the periods indicated, in thousands: Three Months Ended March 31, 2019 2018 Sanofi Genzyme MDCO Vir Sanofi Genzyme MDCO Vir Research and development Clinical trial and manufacturing $ 4,826 $ 1,612 $ 294 $ 10,523 $ 641 $ 554 External services 135 10 236 2,673 — 688 Other 59 50 129 509 — 200 Total research and development expenses $ 5,020 $ 1,672 $ 659 $ 13,705 $ 641 $ 1,442 The research and development expenses incurred for each agreement listed in the table above consist of costs incurred for external development and manufacturing services for which we are reimbursed, licensing payments made to the counterparty to such agreement and costs directly attributable to Sanofi Genzyme transition services. In addition, these expenses include a reasonable estimate of compensation and related costs as billed to our counterparties. As part of our revenue recognition policy adopted on January 1, 2018, the costs in the above table are considered as an input in our determination of transaction price when they relate to consideration received for the delivery of goods or services. For the three months ended March 31, 2019 and 2018, we did not incur material selling, general and administrative expenses related to our collaboration agreements. Sanofi Genzyme Collaboration Collaboration Amendment On April 8, 2019, we and Sanofi Genzyme entered into an amendment to our 2014 Sanofi Genzyme collaboration, which we refer to as the Collaboration Amendment. Under the Collaboration Amendment, we and Sanofi Genzyme agreed to conclude the research and option phase under our collaboration agreement. In connection and simultaneously with entering into the Collaboration Amendment, we and Sanofi Genzyme also entered into the Amended and Restated ALN-AT3 Global License Terms with respect to ALN-AT3 (fitusiran) and certain back-up products, which we refer to as the A&R AT3 License Terms. The A&R AT3 License Terms amend and restate the ALN-AT3 Global License Terms entered into by us and Sanofi Genzyme in January 2018 to modify certain of the business terms. The material collaboration terms for fitusiran, as previously announced, will continue unchanged. In connection with entering into the Collaboration Amendment and the A&R AT3 License Terms, we agreed to advance, at our cost, a selected investigational asset in an undisclosed rare genetic disease through the end of IND-enabling studies. Following completion of such studies, we will transition, at our cost, such asset to Sanofi Genzyme. Thereafter, Sanofi Genzyme will fund all potential future development and commercialization costs for such asset. If this asset is developed and approved, we will be eligible to receive tiered double-digit royalties on global net sales. No changes were made to our Exclusive License Agreement with Sanofi Genzyme, referred to as the Exclusive TTR License, pursuant to which we have global rights for the development and commercialization of ONPATTRO, together with vutrisiran and all back-up products, which remains in full force and effect. Amended and Restated Investor Agreement In connection with the Collaboration Amendment, we and Sanofi Genzyme also entered into an Amended and Restated Investor Agreement, referred to as the A&R Investor Agreement, which amends and restates the Investor Agreement entered into by us and Sanofi Genzyme in February 2014, referred to as the Original Investor Agreement. Pursuant to the A&R Investor Agreement, Sanofi Genzyme is released from the lock-up restrictions under the Original Investor Agreement and is permitted to sell shares of our common stock in transactions approved by us or in fully bought block sale transactions satisfying the conditions set forth in the A&R Investor Agreement. As of January 17, 2019, Sanofi Genzyme owned 10,554,134 shares of our common stock. Under the A&R Investor Agreement, until the earlier of (i) the fifth anniversary of the expiration of the last to expire royalty term or the earlier termination of the collaboration agreement, as amended by the Collaboration Amendment, and (ii) the date after December 31, 2021 on which the beneficial ownership of Sanofi Genzyme and its affiliates no longer represents at least 5% of the outstanding shares of common stock, Sanofi Genzyme and its affiliates will be bound by certain “standstill” provisions, including an agreement not to propose or support a proposal to acquire us. Under the A&R Investor Agreement, Sanofi Genzyme no longer has registration rights or the conditional right to appoint one individual to our board of directors. Sanofi Genzyme continues to be entitled to certain financial information rights until Sanofi Genzyme and its affiliates no longer beneficially own at least 2.5% of our outstanding shares of common stock. |